Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genzyme Biosurgery — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031554 | S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRAN | Genzyme Biosurgery | 2003-07-25 | 67 | 0 |
| K030212 | MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE | Genzyme Biosurgery | 2003-03-27 | 65 | 3 |
| K022989 | RADLITE TISSUE RETRACTOR SYSTEM | Genzyme Biosurgery | 2002-11-25 | 77 | 0 |
| K022410 | SAPH-LOOP LIGATING LOOP | Genzyme Biosurgery | 2002-08-20 | 27 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda